Last updated: 11/03/2018 15:07:08
alcohol interaction study
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to investigate the psychomotor and cognitive effects of alcohol when co-administered with GSK1144814 or matching placebo in healthy subjects.
Trial description: The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Timeframe: pre and post study drug administration
Secondary outcomes:
alcohol level
Timeframe: during and post alcohol administration
blood level of GSK1144814
Timeframe: pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Timeframe: throughout the study pre- and post dose
Interventions:
Enrollment:
21
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JMA. Central nervous system effects of the novel dual NK1/NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2012;75(5):1328-1339.
Medical condition
Alcoholism
Product
GSK1144814
Collaborators
Not applicable
Study date(s)
November 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 – 29.9 kg/m2
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 – 29.9 kg/m2
- Willing to use appropriate contraception methods
Exclusion criteria:
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Positive urine drug screen or positive blood alcohol
- Pregnant, nursing or potential to have a child
- Past history of alcohol dependence or abuse.
- History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
- smokers
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-30-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 113476 can be found on the GSK Clinical Study Register.
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